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Benefits of an Industry-Managed Special Process Supply Chain
Quality Oversight Program for the Medical Device Industry
Ravi Nabar, Ph.D. Steve Niedelman
Value Proposition
This value proposition highlights the value of creating a medical device industry managed supply chain oversight program that will:
Reduce costly supplier-caused recalls
Improve Quality from suppliers (reduced defects)
Reduce risk to patient safety
Provide end to end visibility of the supply chain
Provide an early warning system for supplier quality failures
Enhance compliance with requirements as they apply to critical manufacturing and special processes
Background
FDA’s increased concern over supplier quality due to: Increased number of recalls attributed to supplier quality
Increased dependence on outsourcing and globalization of the supply chain and the associated challenges
Purchasing controls requirements (21CFR 820.50) is number six of top ten cited FDA 483 observations for quality system violations
Purchasing controls has been the target of several enforcement actions (warning letters, consent decrees)
Benefits to Medical Device Industry
Promotes a philosophy of continuous improvement Promotes a culture of patient safety and quality Enhances compliance and quality system effectiveness Promotes best practices to assure patient safety and quality Promotes application of industry/ technical standards/practices Provides opportunity for collaboration between suppliers and OEMs Improves flow-down of OEM requirements to sub-tier suppliers Promotes least burdensome approach by reducing redundancy Enables re-allocation of resources to other areas requiring attention Provides real-time consistent visibility of supply chain quality
Similar NADCAP program in aerospace industry has 20 year history of successful performance and regulatory acceptance
Benefits to Medical Device OEMs
Establishes stringent industry consensus audit criteria based on industry and specific OEM requirements to: Ensure compliance and quality of devices Reduce the risk to patient safety Satisfy the requirements of all participants
Special in-depth process audits are conducted: That are compliant and consistent to accepted
industry/technical standards Conducted by industry recognized, trained and approved
Subject Matter Experts.
Benefits to Medical Device OEMs (continued)
Provides greater visibility of the supply chain at all levels (sub-tiers) Reduces risk of exposure to lower-quality suppliers Provides early warning notification of supply chain quality issues Provides in-depth visibility of audit results and corrective actions Program reduces cost of non-quality Program reduces cost of compliance
Covers three areas of concern: Assesses adequacy and effectiveness of Suppliers’
Quality System at special process levels
Audits are conducted based on robust core industry and OEM specific audit procedures
Process focused product audits
Audits
Benefits to Medical Device Industry OEMs (continued)
Will free up OEM resources to enable focus on supplier development opportunities and/or problem area resolution
Will Improve flow down of OEM requirements to sub-tiers Will make the supplier selection process more efficient Will improve Global supply chain visibility via a web based system Will accredit suppliers based on industry criteria Will support active supplier risk management Will create a shared pool of trained, recognized and approved
subject matter experts among OEMs
Benefits to Medical Device Industry Suppliers
Will enhance the supplier’s compliance status
Will result in fewer redundant onsite audits by multiple OEMs
Will provide standardized process audits with industry-accepted consistent technical requirements
Will lead to greater process discipline & operational efficiency
Will enable continuous improvement resulting in higher quality and lower overall cost
Will help suppliers develop a structured approach to critical manufacturing, special process and product manufacturing
Can use accreditation to increase client-base and business opportunities across the medical device industry
Opportunity to participate in development of audit criteria and the accreditation program
85% of suppliers reported quality improvements after accreditation, including reducing scrap rates, reworks, escapes and defective products (from aerospace survey data)
Benefits to Medical Device Industry Suppliers (continued)
Participants & Acknowledgments*
Manufacturers (20) Abbott Ametek Bard Biomet Baxter Boston Scientific Corp CareFusion Dentsply DuPuy (J&J) Ethicon Endosurgery GE Healthcare Medtronic Philips Healthcare Siemens Steris Stryker Symmetry Medical Terumo Cardiovascular
Systems Zimmer
Suppliers (7) Brunk Industries Flextronics Medical Microtech Welding Paragon Plexus Sanmina Medical Stellartech
Facilitators (2) Performance Review Institute (PRI) King & Spalding
*companies that have sent representatives to meetings and/or are on distribution of minutes as of May 2013
Acknowledgments to the participants and PRI (who hosted these meetings) for the materials contained in this presentation
Chronology
2011-2012
Performance Review Institute (PRI) was approached by several medical device industry OEMs to determine applicability of a NADCAP-like program (Aerospace)
December 5, 2012
Initial Medical Device Industry Roundtable meeting held in Chicago, Il
Attendees included 19 medical device industry stakeholders representing 15 different OEMs and suppliers
Interest was expressed in further exploring an industry managed program
Value proposition sub-team established (GE Healthcare, Stryker Corp, Baxter Healthcare Corp and Philips Healthcare)
2013 Status Value Proposition Sub-Team Meeting (Feb13)
Draft Value Proposition document created
Program Activities 2013-2014
Next Steps 2013-2014 Agreement to sign Letters of Intent
Agreement to Conduct Proof of Concept Audits
4 special process areas agreed upon for development &/or proof of concept audits:
PCBAs, Wiring Harnesses, Heat Treat and Welding, Sterilization (development)
Identify & conduct proof of concept audits at selected supplier sites
Volunteer 1-2 organizational resources from each participating OEM
Identify suppliers and supplier representatives for participating in the program in each process area of interest
Increase awareness among industry representatives & establish program
Provides an avenue to assure supplier quality and medical device quality
Reduces some level of oversight with confidence of supplier meeting accredited industry standards
Enables OEMs to focus on problem suppliers or other issues they would otherwise not be able to
Encourages industry involvement in establishing requirements and standards for audit
Provides industry an opportunity to become more proactive in their supplier quality program
If further information is desired contact either Ravi Nabar ([email protected]) or Steven Niedelman ([email protected])
Summary
Questions?
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